OBJECTIVES: We sought to evaluate the efficacy of recombinant human antithrombin III for restoration of heparin responsiveness in heparin-resistant patients scheduled for cardiac surgery. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled study in heparin-resistant patients undergoing elective cardiac surgery. Patients were considered heparin resistant if the activated clotting time was less than 480 seconds after 400 U/kg heparin. Fifty-two heparin-resistant patients were randomized into 2 cohorts. One cohort received a single bolus (75 U/kg) of recombinant human antithrombin III (n = 28), and the other, the placebo group (n = 24), received a normal saline bolus. If the activated clotting time remained less than 480 seconds, this was defined as treatment failure, and 2 units of fresh frozen plasma were transfused. Patients were monitored for adverse events during hospitalization. RESULTS: Six (21%) of the patients in the recombinant human antithrombin III group received fresh frozen plasma transfusions compared with 22 (92%) of the placebo-treated patients ( P < .001). Two units of fresh frozen plasma did not restore heparin responsiveness. There was no increased incidence of adverse events associated with recombinant human antithrombin III administration. Postoperative 24-hour chest tube bleeding was not different in the 2 groups. Surrogate measures of hemostatic activation suggested that there was less activation of the hemostatic system during cardiopulmonary bypass in the recombinant human antithrombin III group. CONCLUSION: Treatment with recombinant human antithrombin III in a dose of 75 U/kg is effective in restoring heparin responsiveness and promoting therapeutic anticoagulation for cardiopulmonary bypass in the majority of heparin-resistant patients. Two units of fresh frozen plasma were insufficient to restore heparin responsiveness. There was no apparent increase in bleeding associated with recombinant human antithrombin III.
RCT Entities:
OBJECTIVES: We sought to evaluate the efficacy of recombinant humanantithrombin III for restoration of heparin responsiveness in heparin-resistant patients scheduled for cardiac surgery. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled study in heparin-resistant patients undergoing elective cardiac surgery. Patients were considered heparin resistant if the activated clotting time was less than 480 seconds after 400 U/kg heparin. Fifty-two heparin-resistant patients were randomized into 2 cohorts. One cohort received a single bolus (75 U/kg) of recombinant humanantithrombin III (n = 28), and the other, the placebo group (n = 24), received a normal saline bolus. If the activated clotting time remained less than 480 seconds, this was defined as treatment failure, and 2 units of fresh frozen plasma were transfused. Patients were monitored for adverse events during hospitalization. RESULTS: Six (21%) of the patients in the recombinant humanantithrombin III group received fresh frozen plasma transfusions compared with 22 (92%) of the placebo-treated patients ( P < .001). Two units of fresh frozen plasma did not restore heparin responsiveness. There was no increased incidence of adverse events associated with recombinant humanantithrombin III administration. Postoperative 24-hour chest tube bleeding was not different in the 2 groups. Surrogate measures of hemostatic activation suggested that there was less activation of the hemostatic system during cardiopulmonary bypass in the recombinant humanantithrombin III group. CONCLUSION: Treatment with recombinant humanantithrombin III in a dose of 75 U/kg is effective in restoring heparin responsiveness and promoting therapeutic anticoagulation for cardiopulmonary bypass in the majority of heparin-resistant patients. Two units of fresh frozen plasma were insufficient to restore heparin responsiveness. There was no apparent increase in bleeding associated with recombinant humanantithrombin III.
Authors: Sean Garvin; Daniel Fitzgerald; Jochen D Muehlschlegel; Tjörvi E Perry; Amanda A Fox; Stanton K Shernan; Charles D Collard; Sary Aranki; Simon C Body Journal: Anesth Analg Date: 2010-02-08 Impact factor: 5.108
Authors: Ahmed A Khattab; Gjin Ndrepepa; Stefanie Schulz; Franz-Josef Neumann; Julinda Mehilli; Heinz Joachim Büttner; Jürgen Pache; Melchior Seyfarth; Josef Dirschinger; Adnan Kastrati; Peter B Berger; Albert Schömig; Gert Richardt Journal: Clin Res Cardiol Date: 2011-02-11 Impact factor: 5.460
Authors: Sean Garvin; Jochen D Muehlschlegel; Tjörvi E Perry; Junliang Chen; Kuang-Yu Liu; Amanda A Fox; Charles D Collard; Sary F Aranki; Stanton K Shernan; Simon C Body Journal: Anesth Analg Date: 2009-10-09 Impact factor: 5.108
Authors: Trisha E Wong; Yuan-Shung Huang; Jason Weiser; Thomas V Brogan; Samir S Shah; Char M Witmer Journal: J Pediatr Date: 2013-08-06 Impact factor: 4.406